Table 2

Data set definitions and list of analyses

24-Week placebo controlled periodAll Bari-RAHaematological extended setJADVPlatelets extended set*Baseline JADV, JADXJADN
Data sets definitionPlacebo-controlled periods through 24 weeksAll patients with RA with ≥1 dose of BariPlacebo controlled periods and LTE, studies with LTE option onlyStudy-specific analysesPlacebo controlled periods and LTEStudy-specific analysisStudy-specific analyses
TreatmentPlacebo, Bari 4 mgBari 2 mgBari 1, 2, 4, 5, 7, 8, 10 or 15 mg once daily or 2 mg two times per dayPlacebo, Bari 4 mgBari 2 mgBari 4 mgBari 4 mgNAPlacebo, Bari 2 mg, Bari 4 mg
StudiesJADA, JADC, JADN, JADV, JADW, JADXJADA, JADN, JADW, JADXJADA, JADB, JADC, JADN, JADV, JADW, JADX, JADZ and LTEJADA, JADV, JADW, JADX and LTEJADA, JADW, JADX and LTEJADVJADA, JADC, JADN, JADV, JADW, JADX, JADZ and LTEJADV, JADXJADN
CensoringAt rescueNoneAt rescue or dose changeAt rescueAt rescue or dose changeNANA
List of analyses
Baseline characteristics (table 3)XXX
Infection by CTCAE Grade (table 4)XX
AEs leading to d/c (table 5)XXX
Neutrophils and lymphocytes over time (figure 1)XX
Platelets over time (figure 2)XX
Change in haemoglobin over time (figure 3)XX
Reversibility (figures 1B, D and 2B)XX
Neutrophils by hsCRP (online supplemental figure 1)X
Platelets over time by baseline platelet quartile (online supplemental figure 2)X
Mean platelet count and volume (online supplemental figure 3)X
Thrombocytosis by DVT/PE or no (online supplemental figure 4)X
Baseline haemoglobin by hsCRP cat., gender, and age (online supplemental figure 5)X
Haemogloblin over time by baseline hsCRP quartile (online supplemental figure 6)X (Bari 4 mg only)
Change in erythropoetin, reticulocytes and RBC over time (online supplemental figure 7)X
Change in total iron-binding capacity (online supplemental figure 8)X
Platelet count shift (online supplemental table 1)XX
Baseline anaemia by prior medications (online supplemental table 2)X
  • * Data for the follow-up period after treatment discontinuation are included in this analysis.

  • AEs, adverse events; Bari, baricitinib; cat., category; CTCAE, Common Terminology Criteria for Adverse Events; DVT/PE, deep vein thrombosis/pulmonary embolism; hsCRP, high-sensitivity C reactive protein, LTE, long-term extension (JADY study); NA, not applicable; RA, rheumatoid arthritis; RBC, red blood cell.